510(k) · Cleared
Recalled · Class II · 2012Anspach Knotless Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Dec 5, 2005 after a 77-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Dec 5, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- MBI
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
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What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Anspach Suture Anchor Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2012 | Class II | Z-1915-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1875-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1916-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
| Nov 28, 2012 | Class II | Z-1876-2014 | Process design | The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic Knotless Anchor is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments. The Anspach Arthroscopic Knotless Anchor is…
Read the full statement (116 words)
The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic Knotless Anchor is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.
The Anspach Arthroscopic Knotless Anchor is used with specific brarns and types of suture materials including: Arthrotek "MaxBraid"; Smith & Nephew "UltraBraid"; Opus Medical "Magnum Wire"; and Linvetec "Herculine. Suture materials identified as "Braided # 2 polyester" and Arthrex # 2 "Fiberwire" are not recommended for use with The Anspach Arthroscopic Knotless Anchor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052572 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052572: Anspach Knotless Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052572
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026